Ireland
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Enrolling by invitation Observational

Observational Study to Validate a Family Physician Echocardiography Training Programme

NCT07339007 · tracked via the Priya Life Science Spain tracker
Sponsor
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
Phase
Observational
Started
2023-09-12
Last updated
2026-01-14

Condition(s) studied

Heart FailureValvular Heart DiseasesAtrial Fibrillation (AF)Arterial HypertensionCardiomyopathies

Investigational drug(s) / intervention(s)

Cohort of GPs: Training programCohort of patients

Cohort of GPs: Training program: 1. Accredited curriculum: 18 hours of online theory (2.7 CCFCPS credits) with a mandatory 20-item MCQ assessing knowledge and image interpretation. 2. Structured, supervised scanning volume: 4-hour hands-on introductory session on core cardiac views using healthy volunteers, followed by 70 hours of supervised clinical training with a hospital cardiologist, including a predefinied target of 60 FoCUS examinations per GP.

Cohort of patients: Eligible patients are those seen in routine primary care by participating GPs who, based on usual clinical judgment, need an echocardiographic assessment. In these cases, the GP will perform a FoCUS scan as part of the consultation and record a standard set of variables in the study eCRF. When the patient subsequently undergoes a comprehensive echocardiography in cardiology, both assessments (GP FoCUS and cardiology echocardiography) will be paired to evaluate agreement. No additional tests or extra study visits are required beyond usual care.

Study summary

Observational Study on the Validation of Family Doctors' Training in Echocardiography

The Catalan Society of Family and Community Medicine (CAMFiC) developed a structured training program for Family Physicians in focused cardiac ultrasound (FoCUS). This study evaluates GP FoCUS performance against comprehensive echocardiography and assesses training competence.

Developed between September 2023 and November 2025 (92 hours total, including 70 hours supervised practice), participants perform FoCUS on patients with suspected cardiac pathology. The study measures concordance between GP FoCUS and cardiologist echocardiography, and evaluates FoCUS integration into primary care pathways to enhance diagnostic capacity for common cardiac conditions.

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
* Inclusion/Exclusion Criteria for Professionals: Inclusion criteria for professionals in the training program are: * Board-certified specialist in Family and Community Medicine. * Member of the Catalan Society of Family and Community Medicine (CAMFiC). * Access at the workplace to an ultrasound device suitable for FoCUS. * Willing and able to complete all training and study procedures. Exclusion criteria: Not meeting any inclusion criterion. * Inclusion/Exclusion Criteria for Patients: The inclusion criteria for patients are: * Age over 18 years old. * Clinical indication for FoCUS/echocardiographic assessment in routine care. * Attended at a site where a participating GP provides care. * Able to provide written informed consent. Exclusion criteria: * Refusal to participate (no written informed consent) * Severe mental illness * Significant cognitive impairment preventing informed consent.

Primary outcome measure(s)

  • Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography. — Diagnostic agreement assessment in real-world clinical practice following training completion (2024-2027 recruitment period).
    Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography on key cardiac parameters: left ventricular systolic function (preserved vs. reduced), cavity sizes (normal vs. dilated), and significant valve abnormalities (none vs. moderate-severe). Additional parameters include pericardial effusion and IVC dilation. Measured by weighted kappa coefficient comparing blinded independent interpretations of the same patients. Higher κ = better agreement. Clinical competency threshold κ ≥ 0.6 (substantial agreement). Unit of measure: Weighted kappa coefficient (0-1)

Trial sites (1)

FacilityCityRegionStatus
Societat Catalana de Medicina Familiar i Comunitària (CAMFiC) Barcelona Catalonia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07339007 on ClinicalTrials.gov ↗ ← All trials in Spain